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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021875
Company: CEPHALON

Medication Guide

Products on NDA 021875

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUVIGIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	AB	Yes	No
NUVIGIL	ARMODAFINIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
NUVIGIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	AB	Yes	No
NUVIGIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	AB	Yes	Yes
NUVIGIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021875

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2007	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021875s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021875_nuvigil_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2017	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021875Orig1s023ltr.pdf
04/16/2015	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021875Orig1s021ltr.pdf
02/09/2015	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
08/23/2013	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/05/2013	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
01/13/2012	SUPPL-17	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf
01/13/2012	SUPPL-16	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf
10/21/2010	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf
06/28/2013	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021875Orig1s012ltr.pdf
10/21/2010	SUPPL-8	Labeling, REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf
03/26/2009	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021875s006ltr.pdf
10/21/2010	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf

Labels for NDA 021875

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2017	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf
04/16/2015	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf
06/28/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf
10/21/2010	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
10/21/2010	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
10/21/2010	SUPPL-8	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
10/21/2010	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
06/15/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf

Therapeutic Equivalents for NDA 021875

NUVIGIL

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARMODAFINIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	No	AB	206069	AUROBINDO PHARMA LTD
ARMODAFINIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN LTD
ARMODAFINIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	No	AB	200043	MYLAN PHARMS INC
ARMODAFINIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	No	AB	202768	NATCO PHARMA LTD
NUVIGIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	Yes	AB	021875	CEPHALON

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARMODAFINIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	No	AB	206069	AUROBINDO PHARMA LTD
ARMODAFINIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN LTD
ARMODAFINIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	No	AB	200043	MYLAN PHARMS INC
ARMODAFINIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	No	AB	202768	NATCO PHARMA LTD
NUVIGIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	Yes	AB	021875	CEPHALON

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARMODAFINIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	No	AB	206069	AUROBINDO PHARMA LTD
ARMODAFINIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN LTD
ARMODAFINIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	No	AB	200043	MYLAN PHARMS INC
ARMODAFINIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	No	AB	202768	NATCO PHARMA LTD
NUVIGIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	Yes	AB	021875	CEPHALON

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARMODAFINIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	206069	AUROBINDO PHARMA LTD
ARMODAFINIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN LTD
ARMODAFINIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	200043	MYLAN PHARMS INC
ARMODAFINIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	202768	NATCO PHARMA LTD
NUVIGIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	Yes	AB	021875	CEPHALON

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